Data / Medical devices / China / Foshan Topmed Dental Co., Ltd.
Foshan Topmed Dental Co., Ltd.: FDA-registered device maker in Foshan Guangdong, China, 2 510(k) clearances
Foshan Topmed Dental Co., Ltd. is registered with the FDA (registration 3018197668) in Foshan Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3018197668
- Address
- Rm. 401, Floor 4, Block C, #7, Gui Dan Rd. Side Section Luo Cun St., Shi Shan Nanhai District, Foshan Guangdong, China, 528226
- Owner or operator
- Foshan Topmed Dental Co., Ltd. (10095950)
- Roles
- Manufacturer
- First device listed
- May 28, 2026
- Registered through
- 2026
- Brand names listed
- Dental air-motor handpiece(TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41), High speed air turbine handpiece (TM-T1B2, TM-T1M4, TM-T2B2, TM-T2M4, TM-T3B2, TM-T3M4, TM-T4B2,, TM-T4M4, TM-T6B2, TM-T6M4)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2026 | K251389 | High speed air turbine handpiece | EFB | Substantially Equivalent | Foshan Topmed Dental Co., Ltd. | accessdata.fda.gov |
| January 12, 2026 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | EFB | Substantially Equivalent | Foshan Topmed Dental Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated January 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.